A multicenter, open-label, interventional study to verify for association between cognitive decline and olfactory disturbance using a DEmentia Screening Kit in subjects with normal cognitive function, mild cognitive impairment, and Alzheimer s dementia
- Conditions
- Healthy Person/Mild Cognitive Impairment/Alzheimer's Disease
- Registration Number
- JPRN-UMIN000041794
- Lead Sponsor
- Kobayashi Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 220
Not provided
Subjects who meet any of the exclusion criteria will not be enrolled in this study. 1) Subjects who have had an allergic reaction to a fragrance in the past. 2) Pregnant women or subjects who wish to become pregnant. 3) Subjects diagnosed with an olfactory disorder with a definite cause. 4) Subjects with epilepsy or who have a history of epilepsy. 5) Subjects with depression and other psychiatric disorders or who have a history of those. 6) Subjects who have taken a test such as MMSE or MoCA-J within one month of the date of obtaining consent. 7) Subjects who are expected to have a significant effect on the following olfactory functions. - Subjects who reported smoking on the day of the olfactometry. - Subjects who reported on the day of the olfactometry that they were concerned about olfactory dysfunction such as hay fever, rhinitis, or chronic sinusitis. - Subjects who reported using the perfume on the day of the olfactometry. - Subjects who reported consuming strongly smelling food from the day before to the day of the olfactometry. 8) Subjects who are bedridden or unconscious and determined to have severe Alzheimer's disease. 9) Current smoker. 10) Subjects who have been judged by the principal investigator or sub-investigator to be inappropriate for this study, in addition to the reasons listed above.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relationship between cognitive impairment and olfactory deficits in subjects with healthy, mild cognitive impairment, and Alzheimer's disease. 1) Olfactory score by disease level 2) The relationship between olfactory scores and cognitive functioning indicators 3) Discriminability of disease levels using olfactory scores
- Secondary Outcome Measures
Name Time Method 1) The ability to diagnose disease levels using olfactory scores 2) Subgroup analysis by medical history and comorbidity